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sanofi-aventis
1 Onslow Street, Guildford, Surrey, GU1 4YS, UK
Telephone: +44 (0)1483 505 515
Fax: +44 (0)1483 535 432
Medical Information e-mail: uk-medicalinformation@sanofi-aventis.com

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 03/01/2012
SPC Clexane pre-filled syringes

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 03/01/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   19-Dec-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
To update section 4.2 of the SPC and consequently the labelling by including dosing charts.
Updated on 26/07/2011 and displayed until 03/01/2012
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   13-Jul-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Sect 5.1 - text added:

Enoxaparin binds to anti-thrombin III leading to inhibition of coagulation factors IIa and Xa.

Enoxaparin has been shown to increase the blood concentration of Tissue Factor Pathway Inhibitor in healthy volunteers.
Updated on 31/05/2011 and displayed until 26/07/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of Excipients
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   13-May-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 2 -

The following text has been added

 

For full list of excipients, see section 6.1


Section 3 -

The following text has been added

 

Clear, colourless to pale yellow solution.


Section 6.1 - BP removed
Section 9 -

Date of first authorisation: 22 October 1990

Date of latest renewal: 8 August 2002
Updated on 01/04/2011 and displayed until 31/05/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   24-Mar-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2 and 6.5 - text has been amended to include info about safety lock mechanism
Updated on 11/03/2011 and displayed until 01/04/2011
Reasons for adding or updating:
  • New individual SPC (was previously included in combined SPC)
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  enoxaparin sodium